Virtual RealityNCT06127758
Effect of Virtual Reality Glasses Application on Surgical Fear and Anxiety
A study testing virtual reality glasses application and classical training in people with Virtual Reality and Fear, run by Uskudar University.
Trial summary
Purpose and Type of Research:This study will be conducted to examine the effect of virtual reality glasses on surgical fear and anxiety in patients scheduled for cardiovascular surgery. The study is a randomized controlled experimental research. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Fear, Anxiety State
- What is being tested?
- virtual reality glasses application and classical training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Nov 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over,
- Those who will undergo open heart surgery,
- Those who have not had cardiovascular surgery before,
- No communication problems,
- Is conscious and able to answer questions and does not have any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.),
- Does not have a psychiatric disease such as anxiety disorder, panic attack, depression,
- Individuals who do not receive psychiatric treatment such as antipsychotics/anxiolytics will be included in the study.
Who cannot join
- Being under the age of 18,
- Not having open heart surgery,
- Those who have previously undergone cardiovascular surgery,
- Having communication problems,
- Those who are unconscious and unable to answer questions Having any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.),
- Having a psychiatric disease such as anxiety disorder, panic attack, depression,
- Individuals receiving psychiatric treatment such as antipsychotic/anxiolytic will not be included in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Virtual Reality Glasses Application on Surgical Fear and Anxiety in Patients Planned for Open Heart Surgery
Purpose and Type of Research:This study will be conducted to examine the effect of virtual reality glasses on surgical fear and anxiety in patients scheduled for cardiovascular surgery. The study is a randomized controlled experimental research.
Method:The population of the research was approximately 2900 patients who underwent cardiovascular surgery in a year at Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital. The sample size of the study was calculated using the G*Power software program.The study will be completed with 60 people by taking 30 people into the experimental and control groups.Data will be collected with a personal information form, surgical fear scale and state anxiety scale.
Read more
Hypothesis of the Research:
H1: Application of virtual reality glasses reduces surgical fear in patients planned for cardiovascular surgery.
H2: Application of virtual reality glasses reduces anxiety in patients scheduled for cardiovascular surgery.
- Conditions
- Virtual Reality, Fear, Anxiety State, Surgery
- Being tested
- virtual reality glasses application, classical training
- Keywords
- Heart surgery, surgical fear, anxiety, virtual reality
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glasses applicationOther
The experimental group will be given classical training (how to perform the surgery, complications that may occur after the surgery, preparation of fresh blood on the day of surgery, shaving by the barber on the morning of the surgery, how to take care of the mouth after shaving, how to shower with chlorexidine sponges, use of an apron, cap and mask after the shower). After 15 minutes video containing nature images and sounds will be shown through virtual glasses.
classical trainingOther
Information about classical training (how to perform the surgery, complications that may occur after the surgery, preparation of fresh blood on the day of surgery, shaving by the barber on the morning of the surgery, how to take care of the mouth after shaving, how to shower with chlorexidine sponges, use of an apron, cap and mask after the shower) will be given.
| Study group | Role | What they receive |
|---|---|---|
| VRG | Experimental | Not described Receives: Other: virtual reality glasses application; Other: classical training |
| control group | Active comparator | Not described Receives: Other: classical training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
The form prepared by the researchers contains a total of 8 questions containing the patients' introductory information.
Measured: for 1 day
surgical fear scale
There are 8 questions in the scale. The scale is an 11-point Likert type scale with a score between 0 and 10. The scale included two subscales related to the source of fear, each consisting of 4 items. While items 1 to 4 on the scale measure the fear of the short-term consequences of surgery, items 5 to 8 measure the fear of the long-term consequences of surgery (0: not at all afraid, 10: very afraid). An increase in the score indicates an increase in fear.
Measured: for 1 day
state anxiety scale
It consists of a total of 40 items and is scored from 1 to 4. Scale items are evaluated using the "Likert type" scaling method as "1 = not at all", "2 = a little", "3 = a lot", "4 = completely". A high score on the scale indicates a high level of anxiety; A low score indicates a low level of anxiety. In the validity and reliability study of the scale, the alpha value was found to be 0.91.
Measured: for 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sabriye gül, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127758
- Sponsor's protocol ID
- 0031
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Application on Surgical Fear and Anxiety in Patients Planned for Open Heart Surgery
- ClinicalTrials.gov ID
- NCT06127758
- Acronym / sponsor ID
- 0031
- Conditions
- Virtual Reality, Fear, Anxiety State, Surgery
- Keywords
- Heart surgery, surgical fear, anxiety, virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 13 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose and Type of Research:This study will be conducted to examine the effect of virtual reality glasses on surgical fear and anxiety in patients scheduled for cardiovascular surgery. The study is a randomized controlled experimental research.
Method:The population of the research was approximately 2900 patients who underwent cardiovascular surgery in a year at Dr. Siyami Ersek Thoracic and Cardiovascular Surgery Education Research Hospital. The sample size of the study was calculated using the G*Power software program.The study will be completed with 60 people by taking 30 people into the experimental and control groups.Data will be collected with a personal information form, surgical fear scale and state anxiety scale.
Hypothesis of the Research:
H1: Application of virtual reality glasses reduces surgical fear in patients planned for cardiovascular surgery.
H2: Application of virtual reality glasses reduces anxiety in patients scheduled for cardiovascular surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRG | Experimental | Other: virtual reality glasses application, Other: classical training |
| control group | Active comparator | Other: classical training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years and over,
- Those who will undergo open heart surgery,
- Those who have not had cardiovascular surgery before,
- No communication problems,
- Is conscious and able to answer questions and does not have any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.),
Key exclusion criteria (7 listed)
- Being under the age of 18,
- Not having open heart surgery,
- Those who have previously undergone cardiovascular surgery,
- Having communication problems,
- Those who are unconscious and unable to answer questions Having any disorder/disease that affects decision-making ability (dementia, Alzheimer's, etc.),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality glasses applicationThe experimental group will be given classical training (how to perform the surgery, complications that may occur after the surgery, preparation of fresh blood on the day of surgery, shaving by the barber on the morning of the surgery, how to take care of the mouth after shaving, how to shower with chlorexidine sponges, use of an apron, cap and mask after the shower). After 15 minutes video containing nature images and sounds will be shown through virtual glasses. | Other | VRG |
| classical trainingInformation about classical training (how to perform the surgery, complications that may occur after the surgery, preparation of fresh blood on the day of surgery, shaving by the barber on the morning of the surgery, how to take care of the mouth after shaving, how to shower with chlorexidine sponges, use of an apron, cap and mask after the shower) will be given. | Other | VRG, control group |
Primary outcome
Personal Information Form
Time frame: for 1 day
The form prepared by the researchers contains a total of 8 questions containing the patients' introductory information.
surgical fear scale
Time frame: for 1 day
There are 8 questions in the scale. The scale is an 11-point Likert type scale with a score between 0 and 10. The scale included two subscales related to the source of fear, each consisting of 4 items. While items 1 to 4 on the scale measure the fear of the short-term consequences of surgery, items 5 to 8 measure the fear of the long-term consequences of surgery (0: not at all afraid, 10: very afraid). An increase in the score indicates an increase in fear.
state anxiety scale
Time frame: for 1 day
It consists of a total of 40 items and is scored from 1 to 4. Scale items are evaluated using the "Likert type" scaling method as "1 = not at all", "2 = a little", "3 = a lot", "4 = completely". A high score on the scale indicates a high level of anxiety; A low score indicates a low level of anxiety. In the validity and reliability study of the scale, the alpha value was found to be 0.91.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality glasses application and classical training in people with Virtual Reality and Fear, run by Uskudar University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sabriye gul (05434486382, sg7023.70@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: for 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.